Our development and manufacturing network Lonza Nansha, Lonza offers a full range of services at phase-appropriate scale to support feasibility for global excellence assessments, early and late stage clinical trials and commercial manufacture. Our range in advanced chemical synthesis of technologies and flexible business model ensures that services provided meet your specific needs and commercial objectives.

Bend, USA Quakertown, USA Tampa, USA Edinburgh, Scotland Ploërmel, France Visp, Switzerland Monteggio, Switzerland Nansha, China – Particle – Particle – Finished drug – Finished drug – Finished drug – Early and advanced – Particle – API development engineering engineering products products products intermediates engineering and production – Finished drug – API / HPAPI products development and production the next 8 chemical technology sites level... 3 continents

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Lonza Nansha Ltd. Chemical Services 68, Dadaobei Nansha USA +1 201 316 9200 Guangzhou 511455 Japan +81 (0)3 6264 0600 China Europe & Rest of World +41 61 316 81 11 Tel +86 20 34973888 Email [email protected] Fax +86 20 34971188 Email [email protected] lonza.com.cn pharma.lonza.com

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Established in 2003, Lonza Nansha (Lonza Lonza Nansha overview Early phase manufacturing (EPM) Analytical development, services Quality compliance inspection Guangzhou Nansha Ltd) is part of Lonza Group Ltd. and quality control Lonza is committed to Process-oriented Quality Management Nansha is an integrated, world-class API and advance EPM creates a phase-appropriate bridge between the kilo-lab System (PQM) and compliance. API and advanced intermedi- and provides professional services to biopharma­ intermediates development and manufacturing site. and commercial-scale production and serves to facilitate rapid Our analytical development and quality control teams are ates are manufactured according to our PQM which is routinely ceutical customers around the world. Lonza Nansha • Strict commitment to quality and environmental scale-up and support accelerated regulatory file submissions. responsible for method development, validation, transfer of API updated to ensure alignment with regulations and guidelines. is an integral component of our global small molecule stewardship A full chemistry toolkit is in place with extensive experience and intermediate, and ensure the accuracy of product analysis. Nansha strictly follows Lonza global quality policy to establish across multiple synthesis routes, e.g. Grignard reactions, service offering which provides early and advanced • Excellent compliance record and inspection history The laboratories are equipped with modern instrumentation and maintain quality management adherence. hydrogenation, rectification, redox reactions, chiral separation (FDA, PMDA, EMA/MPA) with teams organized to support: technology development, intermediates, active pharmaceutical ingredients and low temperature reactions. In total, 10 reactors (250 L) are technology transfer, product analysis, micro-bio analysis and Quality management system • State-of-the-art facilities and equipment (API), drug product intermediates based on particle in place for EPM to meet specific project needs. Centrifugation data integrity. Laboratory Information Management System Lonza global electronic systems (e.g. DMS, TrackWise, LIMS, engineering, and specialized finished drug products. • Strong research and development capabilities and drying are implemented in a Grade D clean room. (LIMS) is used for lab system management, and data are CDS) is in place at the Nansha site to manage and maintain an • Regulatory expertise and services Our offering is designed to be highly flexible with managed by world-class electronic data systems to global overall quality system and ensure that data is complete, reliable, • Experienced and dedicated team with access to Large scale manufacturing (API) standards and in compliance with Lonza’s global data consistent and accurate. services and business models tailored to specific Lonza’s global network integrity policies. customer and/or drug program needs. A world-class large-scale production facility for API and • Analytical support for laboratory services, Inspection history advanced intermediates is in place to meet late phase clinical e.g. PD, PO, qualification, trouble shooting The Nansha site has an extensive and excellent regulatory As a custom development and manufacturing Research and development and commercial requirements. inspection record: • QC testing of raw materials, package, organization of active pharmaceutical ingredients R&D is an integral component of Lonza Nansha and our • Multipurpose plant with full cGMP compliance intermediates and final products • US FDA on-site inspection in 2010 (APIs), Nansha is committed to providing high- commitment to continued innovation. • Multiple independent production lines • In-process and equipment cleaning samples • EMA on-site inspection and GD FDA on-site inspection quality API services from concept to clinical stages • Dedicated R&D personnel and laboratory Reactor volume range: 6 – 16 m3 • Project registration support in 2014 through commercial manufacturing. Nansha’s • Extensive Instrumentation, e.g. 400 MHz NMR, • Quality and EHS system fully compliant with Lonza global • Micro-bio analyses and stability studies • PMDA on-site inspection in 2015 infrastructure and equipment are designed to the LC-MS, GC-MS, HPLC, GC, IC, etc. standards and Chinese regulations • Data/record retention (LIMS, CDS, Lab instrument system • Sweden MPA on-site inspection in 2018 • Strong data integrity practices same world-class standards for API development • Kilo lab (ISO and cGMP, 10 – 50 L) fulfillment 21 CFR part 11, data back-up system) • Process safety lab (RC-1 and MAK etc.) • Experienced project management and operations team Regulatory services and production as our Visp (Switzerland) site To ensure strong technical support and service excellence, we Lonza provides extensive support for drug registration, • Autoclave (1 – 5 L, max. 60 bar) • Extensive experience and track record with US and European which has a track record of more than 80 years in mid-to-large Biopharma have organized our labs into sub-groups: method development, dossier preparation, submission and maintenance throughout • Solid-phase peptide auto synthesizer method transfer, product analysis, micro-bio analysis and data the lifecycle of a product aligned to individual customer producing custom APIs. These complementary sites • Access to Lonza’s global supply chain infrastructure integrity. requirements. for API development and production serve to provide R&D and technical services • Route scouting and feasibility study for pre-clinical or additional flexibility in meeting your needs and early phase projects provide a high level of global supply security. • Development, optimization and tech-transfer of chemical processes and synthetic routes of small molecule API Lonza Nansha has an excellent inspection history and intermediates, as well as kilo-scale demo production from global regulatory authorities. Our integrated under ISO or cGMP compliance services include route scouting, process devel- • Chemical customer manufacturing from milligram opment and optimization, full analytical method to kilogram scale 80 • Collection of process and quality parameters for development and evaluation, and process validation. years producing customers’ drug registration Regulatory services are in place to support drug • Process optimization (also via simulation) and registration, dossier preparation, submission and customer APIs process development maintenance throughout the lifecycle of a product • Impurity profile studies aligned to individual customer requirements. • Purification and isolation of non-solid product • Synthetic route and process development for product with complex structure and long synthetic sequence Delivering the medicines of tomorrow, today.™